| CTRI Number |
CTRI/2026/02/103643 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of analgesia in patients posted for mandibular fracture surgery. In one group of patients we will be using intavenous analgesia and other group of patients will be giving PNS guided mandibular nerve block for analgesia. |
|
Scientific Title of Study
|
Post-operative analgesia in patients having mandibular fracture surgery after PNS guided mandibular nerve block. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogita Sorte |
| Designation |
Associate Professor |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology, Peoples College of Medical Sciences and Research Centre, Bhopal, 462037
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9806179234 |
| Fax |
|
| Email |
yogitanimje84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogita Sorte |
| Designation |
Associate Professor |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology, Peoples College of Medical Sciences and Research Centre, Bhopal, 462037
MADHYA PRADESH
462037
India |
| Phone |
9806179234 |
| Fax |
|
| Email |
yogitanimje84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogita Sorte |
| Designation |
Associate Professor |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology, Peoples College of Medical Sciences and Research Centre, Bhopal, 462037
MADHYA PRADESH
462037
India |
| Phone |
9806179234 |
| Fax |
|
| Email |
yogitanimje84@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Peoples College of Medical Sciences and Research Centre, Bhopal, 462037. |
|
|
Primary Sponsor
|
| Name |
Peoples College of Medical Sciences and Research CentreBhopal |
| Address |
Department of Anaesthesiology, Peoples College of Medical Sciences and Research Centre, Bhopal, 462037 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yogita Sorte |
Peoples College of Medical Sciences and Research Centre |
Department of Anaesthesiology
Bhopal
MADHYA PRADESH |
09806179234
yogitanimje84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Peoples College of Medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Analgesia with intravenous opioids and NSAIDS in one group and mandibular nerve block in other group of patients. |
In one groups of patients, we will be using intravenous injection of 1-2 microgram per kilogram of Fentanyl, 1 gram Parcetamol and in other groups of patients we will be giving PNS guided mandibular nerve block for post-operative analgesia. |
| Comparator Agent |
Analgesia with intravenous opioids and NSAIDS in one group and mandibular nerve block in other group of patients. |
In one groups of patients, we will be using intravenous injection of 1-2 microgram per kilogram of Fentanyl, 1 gram Parcetamol and in other groups of patients we will be giving PNS guided mandibular nerve block for post-operative analgesia. |
| Intervention |
For all the patients who will be posted for mandibular fracture surgery, we will be using intavenous analgesia in one groups of patients and in other groups of patients we will be giving PNS guided mandibular nerve block for analgesia. |
In one groups of patients, we will be using intravenous injection of 1-2 microgram per kilogram of Fentanyl, 1 gram Parcetamol and in other groups of patients we will be giving PNS guided mandibular nerve block for post-operative analgesia. |
| Comparator Agent |
For all the patients who will be posted for mandibular fracture surgery, we will be using intavenous analgesia in one groups of patients and in other groups of patients we will be giving PNS guided mandibular nerve block for analgesia. |
In one groups of patients, we will be using intravenous injection of 1-2 microgram per kilogram of Fentanyl, 1 gram Parcetamol and in other groups of patients we will be giving PNS guided mandibular nerve block for post-operative analgesia. |
| Intervention |
NSAIDS VERSUS SHIV MIX |
Analgesia with intravenous opioids and NSAIDS in one group and mandibular nerve block in other group of patients. |
| Comparator Agent |
NSAIDS VERSUS SHIV MIX |
Analgesia with intravenous opioids and NSAIDS in one group and mandibular nerve block in other group of patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA grade I and II.
Both female and male.
18-60 years. |
|
| ExclusionCriteria |
| Details |
Patient refusal to give consent,
Patients having history of hypersensitivity to study drugs,
Patients having known history of CNS, CVS, hepatic renal diseases,
Patients having bleeding disorders.
Patients having Hb less than 9 gram %
Patients having infection on injection site,
ASA grade III or higher will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Haemodynamic stability,
duration of analgesia,
patient satisfaction. |
Time recorded when patient will demanded for first rescue analgesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All the patients of ASA physical status I and II posted for mandibular fracture surgery. In group one we will be using intravenous injection of analgesia (Fentanyl and PCM) and in other groups we will be giving PNS guided mandibular nerve block for post-operative analgesia. |